EP1152711B1

EP1152711B1 - Bifurcation stent delivery system

Info

Publication number: EP1152711B1
Application number: EP00905738A
Authority: EP
Inventors: Tracee E. J. Eidenschink
Original assignee: Boston Scientific Ltd Barbados
Current assignee: Boston Scientific Ltd Barbados
Priority date: 1999-01-27
Filing date: 2000-01-26
Publication date: 2005-07-06
Anticipated expiration: 2020-01-26
Also published as: US8398698B2; JP2003525065A; DE60021173D1; US7476243B2; CA2360551A1; US20050192656A1; EP1152711A1; DE60021173T2; ATE299001T1; US20090182406A1; CA2360551C; US20070173920A1; WO2000044307A1; DE60045193D1

Abstract

The present invention is drawn to a system and/or device for deploying a stent at a bifurcation. In one embodiment, the system and/or device for deploying a stent at a bifurcation may include a dual balloon catheter may include an elongate catheter body. Some dual balloon catheters may have a first proximal balloon and a second balloon bonded to at least a portion of the elongate catheter body. In some cases, a guide wire port may be positioned between the first and second balloons.

Description

BACKGROUND OF THE INVENTION

The present invention relates to a system for treating vascular disease. More specifically, the present invention relates to a system for deploying a stent in a bifurcation lesion.
Vascular disease currently represents a prevalent medical condition. Typical vascular disease involves the development of a stenosis in the vasculature. The particular vessel containing the stenosis can be completely blocked (or occluded) or it can simply be narrowed (or restricted). In either case, restriction of the vessel caused by the stenotic lesion results in many well known problems caused by the reduction or cessation of blood circulation through the restricted vessel.
A bifurcation is an area of the vasculature where a first (or parent) vessel is bifurcated into two or more branch vessels. It is not uncommon for stenotic lesions to form in such bifurcations. The stenotic lesions can affect only one of the vessels (i.e., either of the branch vessels or the parent vessel) two of the vessels, or all three vessels.
Vascular stents are also currently well known. Vascular stents typically involve a tubular stent which is movable from a collapsed, low profile, delivery position to an expanded, deployed position. The stent is typically delivered using a stent delivery device, such as a stent delivery catheter. In one common technique, the stent is crimped down to its delivery position over an expandable element, such as a stent deployment balloon. The stent is then advanced using the catheter attached to the stent deployment balloon to the lesion site under any suitable, commonly known visualization technique. The balloon is then expanded to drive the stent from its delivery position to its deployed position in which the outer periphery of the stent frictionally engages the inner periphery of the lumen. In some instances, the lumen is predilated using a conventional dilatation catheter, and then the stent is deployed to maintain the vessel in an unoccluded, and unrestricted position.
Self-expanding stents can also be used. Self-expanding stents are typically formed of a resilient material. The resilient material has sufficient resilience that it can be collapsed to the low profile position and inserted within a delivery device, such as a catheter. Once the catheter is placed at the site of the stenotic lesion, the stent is pushed from within the catheter such that it is no longer constrained in its low profile position. The stent, driven by the resilience of the material, expands to a higher profile, deployed position in which its outer periphery frictionally engages the walls of the stenosed vessel, thereby reducing the restriction in the vessel.
While there have recently been considerable advances in stent design and stent deployment techniques, current methods of treating bifurcation lesions are suboptimal, particularly where both downstream branch vessels are affected by the lesion. Current techniques of dealing with such lesions typically require the deployment of a slotted tube stent across the bifurcation. However, this compromises the ostium of the unstented branch.
Further, once the first stent is deployed, the treating physician must then advance a dilatation balloon between the struts of the stent already deployed in order to dilate the second branch vessel. The physician may then attempt to maneuver a second stent through the struts of the stent already deployed, into the second branch vessel for deployment. This presents significant difficulties. For example, dilating between the struts of the stent already deployed tends to distort that stent. Further, deploying the second stent through the struts of the first stent is not only difficult, but it can also distort the first stent. Thus, the current systems used to alternately deploy stents in a bifurcated lesion have significant disadvantages.
Also, since two guidewires are often used to deploy stents at a bifurcation, the guidewires can become crossed, or somewhat entangled. The deployment systems which are advanced along such guidewires can become caught on the wires, where they cross over one another. This can require additional time and manipulation of the stent deployment system in order to properly deploy the stent at the bifurcation.
Further, some branch vessels can have somewhat smaller diameter lumens than the parent vessels from which they branch. Therefore, stents of different sizes need to be deployed in the parent vessel and the branch vessel. Alternatively, a single stent having a larger diameter portion, and one or more smaller diameter portions, can be deployed at the bifurcation. However, this can lead to difficulty in deployment. For instance, a balloon which is sized to fit within the smaller diameter stent portion, and deploy that portion, may not be large enough to deploy the larger diameter stent portion. Therefore, a plurality of balloon catheters must be used to deploy such stents. US 5 749 825 shows an alternative solution to this problem, where one balloon with a larger diameter is used to dilate the parent vessel and one branch of a bifurcation simultaneously.

SUMMARY OF THE INVENTION

The present invention is drawn to a system for deploying a stent at a bifurcation.
The present invention is a dual balloon stent deployment catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a typical bifurcation lesion.
FIGS. 2 and 3 illustrate a stent having two different deployed diameters.
FIG. 4 illustrates the stent shown in FIGS. 2 and 3 deployed in a bifurcation.
FIG. 5 illustrates a dual-balloon stent deployment system.
FIGS. 6A and 6B illustrate deployment of the stent deployment system illustrated in FIG. 5.
FIG. 7 illustrates another embodiment of a dual-balloon stent deployment system.
FIGS. 8A and 8B illustrate catching of a distal portion of a stent deployment system on crossed or tangled guidewires.
FIGS. 9A-9C illustrate a stent deployment system with a distal sleeve disposed thereabout.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates bifurcation 10 which includes parent vessel 12, first branch vessel 14 and second branch vessel 16. FIG. 1 also illustrates that a bifurcation lesion 18 has developed in bifurcation 10. As illustrated, lesion 18 extends into both branch vessels 14 and 16, and extends slightly into parent vessel 12 as well. Lesion 18 may also be located on only one side of the branch vessel 14 or 16. In either case, it is preferable to stent both branch vessels 14 and 16 to avoid collapsing one. In order to treat bifurcation lesion 18, it may commonly first be predilated with a conventional angioplasty balloon catheter dilatation device.
FIG. 2 is a side view of a stent 20 which can be used to treat a portion of bifurcation 10. Stent 20 includes a first portion 22 and a second portion 24. First portion 22 has a relatively large deployed diameter, while second portion 24 has a somewhat smaller deployed diameter.
FIG. 3 is an end view of stent 20 taken as indicated by arrows 3-3 in FIG. 2. In one illustrative embodiment, portions 22 and 24 of stent 20 are simply discrete stents which have been interwoven, or attached, to one another. Alternatively, stent 20 can be formed by one integral stent formed with portions 22 and 24 being integral with one another. In either case, stent 20 can preferably be deformed to a low profile, collapsed (or deployment) position in which it can be inserted through parent vessel 12 to bifurcation 10. Stent 20 is then deployed, either using its own resilience, or using a balloon deployment system, to its expanded, deployed position illustrated in FIG. 2.
FIG. 4 illustrates stent 20 deployed in bifurcation 10. In FIG. 4, first and second guidewires 26 and 28 are first inserted, through parent vessel 12, to bifurcation 10 such that guidewire 26 has a distal end residing in branch vessel 14 while guidewire 28 has a distal end residing in branch vessel 16. Using a stent deployment system, such as any of those described in greater detail later in the specification, stent 20 is advanced in a low profile, insertion position to the location illustrated in FIG. 4. Stent 20 is then deployed by expanding portions 22 and 24 to the deployed positions illustrated in FIG. 4. In one illustrative embodiment, portion 24 has an outer diameter which, when deployed, frictionally engages the inner diameter of branch vessel 14. Similarly, portion 22 has an outer diameter which, when deployed, is sufficient to frictionally engage the inner diameter of parent vessel 12, to remain in place in bifurcation 10.
FIG. 5 is a side view of a dual-balloon stent deployment system 30 in accordance with the present invention. System 30 is shown with a cross-section of stent 20, in the deployed position, disposed thereon. System 30 includes a proximal catheter 32 having a lumen 34 disposed therein. First and second guidewire lumens (or tubes) 36 and 38 extend from within lumen 34 and extend to distal ends 40 and 42. System 30 also includes a first, proximal balloon 44 and a second, distal balloon 46. Balloon 44 has a proximal end 48 which is sealed to the distal end of catheter 32. While proximal end 48 of balloon 44 can be sealed to either the outer or inner side of catheter 32, it is illustrated in FIG. 5 as being sealed to the outer surface of catheter 32, using, for example, an adhesive. Balloon 44 also has a distal end 50 which is sealed, with a fluid tight seal, about guidewire tube 36 and a portion of the proximal end 52 of balloon 46.
Balloon 46 includes a proximal end 52 which is also fluidly sealed partially to an inside surface of the distal waist of balloon 44 and partially to guidewire lumen 38. However, an inflation lumen 54 extends from the interior of balloon 44, through the proximal end 52 of balloon 46, and communicates with the interior or balloon 46. Balloon 46 further includes a distal end 56 which is sealed to the outer surface of guidewire lumen 42. Therefore, an inflation lumen for inflating balloons 44 and 46 is defined by lumen 34 of catheter 42, and lumen 54 disposed about at least a portion of guidewire tubes 36 and 38.
Guidewire lumen 38 extends from lumen 34 distally through both balloons 44 and 46, and protrudes out the distal end 56 of balloon 46. Guidewire lumen 36, on the other hand (and as will be disclosed in greater detail later in the specification) is used to track a guidewire which extends down a branching vessel. Guidewire lumen 38 has a distal end 40 which extends out from within the distal end 50 of balloon 44, and extends to a position outside of balloon 46. Both balloons 44 and 46 can preferably be-collapsed to a low profile, insertion position. However, balloon 44 has a relatively large inflated diameter for driving deployment of the larger diameter portion 22 of stent 20. Balloon 46, on the other hand, has a smaller inflated diameter for driving deployment of the smaller diameter stent portion 24 of stent 20.
FIGS. 6A and 6B illustrate the deployment of stent 20 utilizing system 30 illustrated in FIG. 5. FIG. 6A illustrates system 30 in the insertion position. First, guidewires 26 and 28 are advanced through the vasculature to bifurcation 10, such that they reside within branch vessels 14 and 16, pespectively. It should be noted that system 30 can be backloaded onto guidewires 26 and 28. In that case, prior to inserting guidewires 26 and 28, system 30 is loaded onto the guidewire such that guidewire 26 resides within guidewire tube 38 while guidewire 28 resides within tube 30. Alternatively, system 30 can be loaded onto guidewires 26 and 28 from the proximal end of the guidewires. In either case, after the guidewires are positioned appropriately, system 30 is advanced using catheter 32 through the vasculature (and may be advanced through a guide catheter 58) to bifurcation 10. System 30 is then further advanced such that stent portion 24 follows guidewire 26 and resides within branch vessel 14.
Once in the position illustrated in FIG. 6A, fluid is introduced into balloons 44 and 46 through catheter 32, to inflate the balloons. This drives stent portions 22 and 24 of stent 20 into the deployed position illustrated in FIG. 6B. In the deployed position, the outer diameter of stent portions 22 and 24 are sufficient to frictionally engage the interior vessel walls of parent vessel 12 and branch vessel 14, respectively, such that stent 20 is frictionally held in place in bifurcation 10. The lumens 44 and 46 are then deflated, and system 30 is removed from within stent 20. Guidewires 26 and 28 are then removed from bifurcation 10, leaving stent 20 deployed in place.
System 30 preferably employs balloons 44 and 46 which have steep proximal and distal cone angles in order to reduce any gap between the balloons, this increases the ability to exert adequate deployment force on stent portions 22 and 24. Similarly, post delivery dilatation may be used in order to further dilate the lesion from within the deployed stent 20.
FIG. 7 illustrates a side view of another embodiment of a dual-balloon stent deployment system 60 in accordance with one aspect of the present invention. System 60 has a number of items which are similar to system 30 shown in FIG. 5, and those items are similarly numbered in FIG. 7. System 60 includes a proximal balloon 62 which has a proximal end 64 and a distal end 66. The proximal end 64 in balloon 62 is sealed about the distal end of catheter 32. The interior of balloon 62 communicates with lumen 34 of catheter 32. The distal end 66 of balloon 62 is formed in a cone configuration. A radially interior portion is sealed about guidewire tubes 36 and 38, leaving an inflation lumen 68 therebetween, which communicates with the interior of balloon 46. The radial outward portion of the distal end 66 of balloon 62, when inflated, assumes an outer diameter which is substantially the same as the maximum diameter of the remainder of balloon 62. However, the distal end 66 is formed in a reverse cone shape such that the radial outward portion of the distal end 66 is substantially tubular in shape. The balloon tapers proximally along a portion 70 to the inner diameter portion of balloon 62.
In this way, the outer diameter of balloon 62 obtains a substantially greater size, at its extreme distal end, than balloon 44 in system 30. This assists in deploying portion 22 of stent 20. Again, post-delivery dilatation may be used to further advance stent portions 22 and 24 toward the wall of vessels 12 and 14, respectively. Stent deployment system 60 is deployed in a similar fashion as stent deployment system 30, illustrated with respect to FIGS. 6A and 6B.
FIGS. 8A and 8B illustrate a problem which can be encountered in deploying a stent in a bifurcation. FIG. 8A illustrates a stent deployment system 72 located just proximally of bifurcation 10. Stent deployment system 72 includes a distal stent portion 74 which has a distal end 76. FIG. 8A also illustrates that guidewires 26 and 28 are crossed over one another in a cross-over region 78. As deployment system 72 is advanced distally, the distal end 76 of stent portion 74 encounters cross over region 78. FIG. 8B illustrates that the distal end 76 of stent portion 74 can actually catch, and hang up on, a portion of guidewire 28 which is crossed over guidewire 26. This makes it very difficult, if not impossible, to continue to advance stent deployment system 72 distally over guidewires 26 and 28. Instead, system 72 must be withdrawn proximally, and the guidewires 26 and 28 must be remanipulated or deployment system 72 must be torqued (rotated about its longitudinal axis) or otherwise maneuvered, in an attempt to loosen guidewire 28 from the distal end 76 of stent portion 74.
FIG. 9A illustrates stent deployment system 60, as discussed with respect to FIG. 7, but with the addition of a distal sleeve 80 or a proximal sleeve 82 or both disposed about the distal end of stent portion 24 and the proximal end of stent portion 22, respectively. Distal sleeve 80 and proximal sleeve 82 are provided in order to minimize the likelihood that the longitudinal ends of stent 20 will catch or engage any unwanted obstacles, such as tissue or guidewires. The siteves 80 and 82 are described in greater detail in U.S. Patent No. 4,950,227. Briefly, sleeves 80 and 82 are illustratively formed of silicone and are approximately 2 cm in length. Sleeve 80 is fixed to the distal end 42 of guidewire lumen 38 using adhesive or welding. Similarly, the proximal end of sleeve 82 is fixed to the distal end of catheter 32, using a suitable adhesive. Such adhesive may, for example, be comprised of a urethane bead. Sleeves 80 and 82 overlap stent portions 24 and 22, respectively, by a distance which is approximately 3 mm. Further, in one embodiment, sleeves 80 and 82 have tapered distal edges. In a further embodiment, sleeves 80 and 82 have tapered distal and proximal edges. This facilitates the transfer of system 60 within the vasculature, while decreasing the tendency to catch or engage undesired obstacles.
FIGS. 9B and 9C illustrate the deployment of stent portion 24 and the interaction of stent portion 24 with sleeve 80. A similar interaction is obtained between sleeve 82 and the proximal end of stent portion 22. As stent portion 24 is deployed, balloon 46 is inflated and the distal end of stent portion 24 is released from within sleeve 80. This is illustrated in FIG. 9B. Then, after stent portion 24 is deployed and balloon 46 is deflated (and thus radially retracted) sleeve 80 contracts about the distal end of balloon 46. The deflation of balloon 46 facilitates removal of balloon 46, as well as sleeve 80, from within the deployed stent portion 24, as deployment system 60 is axially removed from the vasculature. It should be noted that sleeves 80 and 82 can be used on substantially any of the embodiments described herein.
Thus, it can be seen that the present invention provides a system for deploying a stent at a bifurcation. The system includes a variety of dual-balloon delivery and deployment systems.
Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the scope of the invention as defined by the claims.

Claims

A dual balloon catheter (30) comprising:

an elongate catheter body (32) having a distal end, at least one guide wire lumen (36, 38) therethrough and an inflation lumen (34) therein;

a first proximal balloon (44) having a proximal portion (48) bonded to the catheter (32); and

a second distal balloon (46) having a distal portion (56) bonded to the catheter distally of the first balloon, the proximal and distal balloons in fluid communication with the inflation lumen (34); characterised in that the catheter further comprises:

a guide wire port positioned between the first and second balloons and in communication with the at least one guide wire lumen (36).
The dual balloon catheter of claim 1 wherein a distal portion of the first balloon is bonded to a proximal portion of the second balloon.
The dual balloon catheter of claim 1 or 2 further comprising:

a second guide wire lumen (38) having a distal exit port distal of the distal portion of the second balloon.
The dual balloon catheter of any one of the preceding claims further comprising:

a distal waist means (50) on the first balloon configured to closely fit about a proximal waist (52) of the second balloon.
The dual balloon catheter of any one of the preceding claims wherein the first balloon has a first axis offset from a second axis of the second balloon.